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Completed Phase 3 Interventional Results available

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

ClinicalTrials.gov ID: NCT01499082

Public ClinicalTrials.gov record NCT01499082. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 6:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus Secondary Objectives: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

Study identification

NCT ID
NCT01499082
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
807 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2011 (Type not available)
Primary completion
Jan 2013 (Actual)
Completion
Sep 2013 (Actual)
Last update posted
Mar 25, 2022

2011 – 2013

United States locations

U.S. sites
95
U.S. states
31
U.S. cities
81
Facility City State ZIP Site status
Investigational Site Number 840156 Chandler Arizona 85224 —
Investigational Site Number 840102 Glendale Arizona 85306 —
Investigational Site Number 840071 Phoenix Arizona 85028 —
Investigational Site Number 840121 Sun City Arizona 85351 —
Investigational Site Number 840070 Tempe Arizona 85282 —
Investigational Site Number 840016 Hot Springs Arkansas 71913 —
Investigational Site Number 840015 Little Rock Arkansas 72205 —
Investigational Site Number 840124 Little Rock Arkansas 72205 —
Investigational Site Number 840032 Searcy Arkansas 72143 —
Investigational Site Number 840076 Anaheim California 92801 —
Investigational Site Number 840133 Encino California 91436 —
Investigational Site Number 840062 Greenbrae California 94904 —
Investigational Site Number 840057 Huntington Beach California 92648 —
Investigational Site Number 840059 La Jolla California 92037 —
Investigational Site Number 840004 La Mesa California 91942 —
Investigational Site Number 840099 Mission Hills California 91345 —
Investigational Site Number 840107 Palm Springs California 92262 —
Investigational Site Number 840005 San Diego California 92161 —
Investigational Site Number 840013 Tustin California 92780 —
Investigational Site Number 840002 Walnut Creek California 94598 —
Investigational Site Number 840114 Colorado Springs Colorado 80906 —
Investigational Site Number 840136 Colorado Springs Colorado 80910 —
Investigational Site Number 840092 Longmont Colorado 80501 —
Investigational Site Number 840049 Daytona Beach Florida 32117 —
Investigational Site Number 840050 Hollywood Florida 33021 —
Investigational Site Number 840086 Jacksonville Florida 32204 —
Investigational Site Number 840011 Jacksonville Florida 32216 —
Investigational Site Number 840009 Jacksonville Florida 32258 —
Investigational Site Number 840023 New Port Richey Florida 34652 —
Investigational Site Number 840012 Ocoee Florida 34761 —
Investigational Site Number 840148 Palm Harbor Florida 34684 —
Investigational Site Number 840055 Lawrenceville Georgia 30045 —
Investigational Site Number 840052 Idaho Falls Idaho 83404 —
Investigational Site Number 840117 Nampa Idaho 83686 —
Investigational Site Number 840020 McHenry Illinois 60050 —
Investigational Site Number 840019 Springfield Illinois 62704 —
Investigational Site Number 840078 Avon Indiana 46123 —
Investigational Site Number 840089 Avon Indiana 46123 —
Investigational Site Number 840097 Avon Indiana 46123 —
Investigational Site Number 840098 Avon Indiana 46123 —
Investigational Site Number 840100 Avon Indiana 46123 —
Investigational Site Number 840127 Vincennes Indiana 47591 —
Investigational Site Number 840116 Des Moines Iowa 50314 —
Investigational Site Number 840003 Wichita Kansas 67211 —
Investigational Site Number 840080 Lexington Kentucky 40504 —
Investigational Site Number 840042 Paducah Kentucky 42003 —
Investigational Site Number 840036 Baltimore Maryland 21237 —
Investigational Site Number 840155 Baltimore Maryland 21237 —
Investigational Site Number 840034 Rockville Maryland 20852 —
Investigational Site Number 840065 Ann Arbor Michigan 48106 —
Investigational Site Number 840066 Dearborn Michigan 48124 —
Investigational Site Number 840103 Flint Michigan 48504 —
Investigational Site Number 840126 Kalamazoo Michigan 49048 —
Investigational Site Number 840022 Southfield Michigan 48034 —
Investigational Site Number 840143 Chaska Minnesota 55318 —
Investigational Site Number 840068 Eagan Minnesota 55122 —
Investigational Site Number 840085 Minneapolis Minnesota 55416 —
Investigational Site Number 840053 Kalispell Montana 59901 —
Investigational Site Number 840090 Fremont Nebraska 68025 —
Investigational Site Number 840091 Omaha Nebraska 68130 —
Investigational Site Number 840058 Las Vegas Nevada 89148 —
Investigational Site Number 840043 Brick New Jersey 08274 —
Investigational Site Number 840152 Toms River New Jersey 08721 —
Investigational Site Number 840146 Asheville North Carolina 28801 —
Investigational Site Number 840145 Hickory North Carolina 28601 —
Investigational Site Number 840045 Wilmington North Carolina 28401 —
Investigational Site Number 840067 Fargo North Dakota 58103 —
Investigational Site Number 840008 Cincinnati Ohio 45236 —
Investigational Site Number 840106 Columbus Ohio 43213 —
Investigational Site Number 840123 Dayton Ohio 45439 —
Investigational Site Number 840119 Maumee Ohio 43537 —
Investigational Site Number 840122 Mentor Ohio 44060 —
Investigational Site Number 840083 Medford Oregon 97504 —
Investigational Site Number 840084 Portland Oregon 97239-3098 —
Investigational Site Number 840007 Uniontown Pennsylvania 15401 —
Investigational Site Number 840079 Greer South Carolina 29651 —
Investigational Site Number 840048 Rapid City South Dakota 57701 —
Investigational Site Number 840039 Chattanooga Tennessee 37404 —
Investigational Site Number 840159 Knoxville Tennessee 37912 —
Investigational Site Number 840021 Austin Texas 78731 —
Investigational Site Number 840129 Austin Texas 78731 —
Investigational Site Number 840081 Austin Texas 78758 —
Investigational Site Number 840001 Dallas Texas 75230 —
Investigational Site Number 840047 Dallas Texas 75246 —
Investigational Site Number 840082 Houston Texas 77096 —
Investigational Site Number 840120 Hurst Texas 76054 —
Investigational Site Number 840010 Draper Utah 84020 —
Investigational Site Number 840060 Ogden Utah 84403 —
Investigational Site Number 840035 Chesapeake Virginia 23321 —
Investigational Site Number 840074 Norfolk Virginia 23502 —
Investigational Site Number 840112 Norfolk Virginia 23507 —
Investigational Site Number 840041 Norfolk Virginia 23510 —
Investigational Site Number 840104 Richmond Virginia 23235 —
Investigational Site Number 840075 Williamsburg Virginia 23185 —
Investigational Site Number 840018 Milwaukee Wisconsin 53209-0996 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01499082, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 25, 2022 · Synced Oct 27, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01499082 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →